module a: clinical research coordinator roles and responsibilities

Version: Final 24-Mar-2010 1

MODULE A:Clinical Research Coordinator

Roles and Responsibilities

Denise K. Thwing, MAS, RN, CCRAAssociate Director Project

Management


Key Players

Clinical Research

Coordinator

Subjects/families

Sponsor

IRB

PI/Sub-Is


Ideal Characteristics Scientific/medical background Interest in advancing medical needs of

patients Interest in research Detail oriented Organizational Skills Ability to multi-task People skills Communication skills Creative and Flexible


Roles and Responsibilities The definition of a CRC as per the

Association of Clinical Research Professionals is: “A Clinical Research Coordinator, Study Site Research Nurse or Study Site Coordinator works at a clinical research site under the direction of a principle investigator, whose research activities are conducted under Good Clinical Practice regulations.


Roles and Responsibilities Roles and responsibilities have not been

formally described in the ICH-GCP guidelines. Their role remains vague and ill defined.

CRC responsibilities vary greatly from institution to institution.

Responsibilities depend on what is delegated by the Investigator.


Roles and Responsibilities Administrative Duties

Protocol feasibility for the site Incidence and prevalence rates for major diseases Contracts

Budgets per institution/sponsor Assist/Complete IRB documents

Completion of required templates Interacts regularly with PIs, IRBs, Sponsors,

CRAs, Clinics, Pharmacies, Radiology Facilities, etc. Know your hours of operation, clinic schedule, PI,

sub-I availability Maintain contact information


Roles and Responsibilities Maintain Documents

IRB Correspondence/ICFs

Source documents

CRFs/eCRFs

CVs, local lab certificates

Study reference manual


Roles and Responsibilities Coordinate/participate in Monitoring visits

Ensure all materials are prepared for reviewSecond QC ideal

Reserve space for CRAs/sponsors

Allow time to spend with CRAs to make corrections/reply to DCFs

Coordinate activities staff


Roles and ResponsibilitiesSet-up and maintain

documents

Coordinate MVs

Facilitate Site Audits

Interact with subjects

Maintain site training


Roles and Responsibilities Interactions with Subjects/families

Recruit/screen IRB approved advertising/posters/TV/Radio

Consent Verify all elements are present Verify correct version

Conduct study visit procedures Know your protocol Verify CRF captures all data in the protocol Drug dispensing/accountability

Retention/follow-up/study reminder appt cards/calendars


Roles and Responsibilities 1.1 Time and Events Schedule

(a) Complete vital signs, including height (Visit 1 only), weight, respiratory rate, temperature, and orthostatic (sitting, immediate standing and 2-minute standing) blood pressure and pulse rate measurements. (b) Subjects will be administered one ECG at Visits 1 and Day 2; subjects will be instructed to remain in a supine position 2 minutes prior to each ECG evaluation. (c) Echocardiogram should be scheduled 2 weeks prior to Visit 3 to insure results are available for review at this visit. (d) First 24 hour urine collection to begin 24 hours prior to dose and second 24 hour urine collection to begin at time of dose. Urine samples will be collected and labeled at 2, 4 and 24 hour increments. (e)Visit 1 clinical laboratory tests will include chemistry, hematology, endocrinology, urinalysis, and HIV, Hep B & C antibody screen. Day 1and Day 2 clinical laboratory tests will include chemistry, hematology, endocrinology, and urinalysis as well as plasma rennin, aldosterone, pharmacokinetics and (baseline/predose, 0.25 hr, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr and 24 hr), baseline sample for anti-PL-3994 antibody formation and 24 hour urine (including measurement of electrolytes). Eight week follow-up clinical laboratory test will include chemistry, urinalysis, as well as an analysis for potential antibody formation. Samples for immunology analysis will be batched and processed at the end of the study.

(f) Dosing will begin with two of the four subjects in the first cohort. Dosing for the next two subjects will begin 2 hours after the first two subjects are dosed.

(g) The monitor will be set to take a measurement at baseline, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes and then every 15 minutes. Should a clinically significant change in blood pressure be detected, it must be confirmed with a manual cuff measurement within 5 minutes.Subjects should be encouraged to remain comfortably seated to the extent possible during the 8 hour period, except as required by other study procedures.

Evaluations

Visit 1

(Screening Day -21)

Visit 2 Visit 3 30 days

Follow Up (+ 3 days)

Day -2

Day -1 Day 1 Day 2

Informed Consent X Medical History X Physical Examination X X Vital Signs(a) X X X X X 12-Lead Resting ECG(b) X X X Echocardiogram(c) X X Continuous Urine Collection(d) X X X Urinalysis for Drugs of Abuse X X Clinical Laboratory Tests(e) X X X X Verify Inclusion & Exclusion Criteria X X Record Fluid and Food Intake X X X X Administer Study Drug(f) X Continuous Blood Pressure Monitoring Post-Dose (≥8 hours post-dose)

X

Record Concomitant Drug Usage X X X X X X AE Assessment X X X X X


Roles and Responsibilities Challenges

On time patient visit schedule Clinic space Investigator availability Time to record legible data, review for accuracy/

answer DCFs Diary compliance Lab assessments/difficult sticks Initial and ongoing assessment lab/clinical data

Change from baseline/causesAbnormal values/why?Ensure patient compliance with protocol/deviations


Roles and Responsibilities A survey of trial subjects showed that

listening, providing information and answering questions from subjects are some of the most important aspects of the role of the CRC.

In one survey where study subjects reported an excellent relationship with the CRC, more than 88% felt that the CRC positively influenced their participation in the trial. The CRC/subject relationship positively influenced

subject compliance. J.Obstet.Gynecol Neonal Nursing:1997 May-Jun; 26 (3): 279-85


Roles and Responsibilities Laboratory

Obtain/prepare samples Know protocol samples/time points

Know refrigerator/freezer requirements

OHSA regulations

Know courier/package, country requirements and pick-up locations/times

IATA certification www.iata.org CLIA – Clinical Laboratory Improvement Amendments CAP – College of American Pathologists

http://www.iata.org/


Roles and Responsibilities Personal Responsibilities

Training/stay currentGCP/ICH yearlyAttend conferences/accreditation/ACRP/SoCRAIRB policies and procedureswww.fda.gov

Reference room: Code of Federal Regulations

http://www.fda.gov/

module a: clinical research coordinator roles and responsibilities

Documents

clinical research site

research activities

study subjects

crc responsibilities

study site research

study site coordinator

responsibilities denise

legible data